Beruflich Dokumente
Kultur Dokumente
OF SEXUAL
& REPRODUCTIVE
HEALTHCARE
ISSN 1755-103X
ABBREVIATIONS USED
GRADING OF RECOMMENDATIONS
C Evidence is limited but the advice relies on expert opinion and has the
endorsement of respected authorities
✓ Good Practice Point where no evidence exists but where best practice is based
on the clinical experience of the multidisciplinary group
Permission granted to reproduce for personal and educational use only. Commercial copying, hiring and lending are prohibited.
CEU GUIDANCE
CONTENTS
© FSRH 2010 i
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ii © FSRH 2010
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B Women can be advised that combined hormonal contraception (CHC) use in the
perimenopause may help to maintain bone mineral density.
C Use of CHC may help to reduce menstrual pain and bleeding.
C Women can be advised that in clinical practice CHC may reduce menopausal
symptoms.
✓ Women experiencing menopausal symptoms while using CHC may wish to try an
extended regimen.
B CHC use provides a protective effect against ovarian and endometrial cancer that
continues for 15 years or more after stopping CHC.
B Women can be advised that there may be a reduction in the incidence of benign
breast disease with CHC use.
B Women can be advised that there is a reduction in the risk of colorectal cancer with
CHC use.
B Women can be advised that there may be a small additional risk of breast cancer with
CHC use, which reduces to no risk 10 years after stopping CHC use.
B Women who are aged 35 years or over and smoke should be advised that the risks of
using CHC usually outweigh the benefits.
B Clinicians should be aware that there may be a very small increased risk of ischaemic
stroke with CHC use.
C Women with cardiovascular disease, stroke or migraine with aura should be advised
against the use of CHC.
✓ Practitioners who are prescribing CHC to women aged over 40 years may wish to
consider a pill with <30 µg ethinylestradiol as a suitable first choice.
B Hypertension may increase the risk of stroke and myocardial infarction (MI) in those
using COC.
C Blood pressure should be checked before and at least 6 months after initiating a
woman aged over 40 years on CHC and monitored at least annually thereafter.
Progestogen-only Contraception
B Women can be informed that there is no conclusive evidence of a link between
progestogen-only methods and breast cancer.
C Progestogen-only methods may help to alleviate dysmenorrhoea.
✓ Women should be advised that altered bleeding patterns are common with use of
progestogen-only contraception (POC).
B Women should be advised that the levonorgestrel-releasing intrauterine system
(LNG-IUS) can be used for the treatment of heavy menstrual bleeding once pathology
has been excluded.
B Women should be informed that the progestogen-only injectable is associated with a
small loss of BMD, which usually recovers after discontinuation.
✓ Women who wish to continue using depot medroxyprogesterone acetate (DMPA)
should be reviewed every 2 years to assess the benefits and potential risks. Users of
DMPA should be supported in their choice of whether or not to continue using DMPA
up to a maximum recommended age of 50 years.
B Women can be advised that although the data are limited, POC does not appear to
increase the risk of stroke or MI, and there is little or no increase in venous
thromboembolism risk.
C Caution is required when prescribing DMPA to women with cardiovascular risk factors
due to the effects of progestogens on lipids.
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Stopping Contraception
✓ Women using non-hormonal methods of contraception can be advised to stop
contraception after 1 year of amenorrhoea if aged over 50 years, 2 years if the woman
is aged under 50 years.
C After counselling (about declining fertility, risks associated with insertion, and
contraceptive efficacy), women who have a Cu-IUD containing ≥300 mm2 copper,
inserted at or over the age of 40 years, can retain the device until the menopause or
until contraception is no longer required.
✓ Women who continue to use their IUD until contraception is no longer required should
be advised to return to have the device removed.
✓ Women using exogenous hormones should be advised that amenorrhoea is not a
reliable indicator of ovarian failure.
✓ In women using contraceptive hormones, follicle-stimulating hormone (FSH) levels may
be used to help diagnose the menopause, but should be restricted to women over the
age of 50 years and to those using progestogen-only methods.
✓ FSH is not a reliable indicator of ovarian failure in women using combined hormones,
even if measured during the hormone-free interval.
✓ Women over the age of 50 years who are amenorrhoeic and wish to stop POC can
have their FSH levels checked. If the level is ≥30 IU/L the FSH should be repeated after
6 weeks. If the second FSH level is ≥30 IU/L contraception can be stopped after 1 year.
✓ Women who have their LNG-IUS inserted for contraception at the age of 45 years or
over can use the device for 7 years (off licence) or if amenorrhoeic until the
menopause, after which the device should be removed.
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vi © FSRH 2010
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FACULTY
OF SEXUAL
& REPRODUCTIVE
Faculty of Sexual and Reproductive Healthcare
HEALTHCARE
Clinical Effectiveness Unit
A unit funded by the FSRH and supported by NHS Greater Glasgow & Clyde
to provide guidance on evidence-based practice
1 Background
Contraceptive choice for women aged over 40 years may be influenced by many factors:
frequency of intercourse, natural decline in fertility, sexual problems, the wish for non-
contraceptive benefits, menstrual dysfunction and concurrent medical conditions.
This guidance provides evidence-based recommendations to guide clinicians, women and
couples in making decisions about contraceptive choices, including stopping contraception.
It is beyond the scope of this guidance to make recommendations on management of the
perimenopause and use of hormone replacement therapy (HRT), except in the context of
contraceptive use.
Recommendations are based on available evidence and consensus opinion of experts. They
should be used to guide clinical practice but they are not intended to serve alone as a
standard of medical care or to replace clinical judgement in the management of individual
cases. A key to the Grading of Recommendations, based on levels of evidence, is provided
on the inside front cover of this document. Details of the methods used by the Clinical
Effectiveness Unit (CEU) in developing this guidance are outlined in Appendix 1.
B Women should be informed that although a natural decline in fertility occurs from their
mid-30s, effective contraception is required to prevent an unintended pregnancy.
2.2 Pregnancy
There is an increasing trend within the UK for women to have children later in life.2,3 The live
birth rate for all age groups in England and Wales has increased since 2007, with the greatest
increase seen in women aged 40 years and over (live birth rate was 12.0/1000 women in 2007
and 12.6/1000 in 2008), with the number of live births to mothers aged 40 and over nearly
doubling from 131555 in 1998 to 261419 in 2008.2,4 Women in their 40s also experience
unintended pregnancies and some opt for an abortion. In Scotland in 2008, the rate of
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abortion in women aged over 40 was 2.2 per 1000;5 in England and Wales amongst those
aged 40–44 years it was 4 per 1000 (n = 7663), which was almost equivalent to the rates for
young women under the age of 16 (n = 4113).
Although more individuals are delaying starting a family until later in life, later childbirth is
associated with worsening reproductive outcomes: more infertility and medical co-morbidity,
and an increase in maternal and fetal morbidity and mortality. The maternal mortality rate in
the UK is highest in the 40 years and over age group, with a rate of 29.4 per 100 000 maternities
in 2003–2005 compared with a rate of 14.0 per 100 000 for all ages.6
In addition, the risk of pregnancy affected by trisomy 21(Down syndrome) rises from 1 in 1600
in mothers aged <23 years to 1 in 40 for mothers aged 43 years.7 A prospective multicentre
study of singleton pregnancies found that maternal age was associated with an increased risk
of miscarriage, gestational diabetes, placental praevia and Caesarean section.8 In the same
study, maternal age greater than 40 years was associated with placental abruption, preterm
delivery, low birth weight and increased perinatal mortality.8
The evidence for increased risk of non-chromosomal congenital abnormality in the older
maternal age group is mixed. However, a recent review of data from the EUROCAT congenital
anomaly register is reassuring. Increasing age alone does not appear to be a risk factor for
non-chromosomal abnormality but reproductive, social, ethnic, environmental and lifestyle
factors together with maternal age may have an effect.9
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Table 1 UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) categories based on age10
Table 2 Definition of UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) categories10
Category Definition
UKMEC 1 A condition for which there is no restriction for the use of the contraceptive method.
UKMEC 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks.
UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method.
Provision of a method requires expert clinical judgement and/or referral to a specialist since use of the
method is not usually recommended unless other more appropriate methods are not available or
acceptable.
UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used.
detailed information about the health risks and benefits associated with individual methods,
practitioners should refer to the appropriate method-specific guidance produced by the CEU.
C Women aged over 40 years can be advised that no contraceptive method is contraindicated
by age alone.
✓ When prescribing contraception for women aged over 40 years, health professionals should
be guided by UKMEC. Clinical judgement is also required, particularly when prescribing for
women with multiple medical and social factors.
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LARCs,14–16 other than with the progestogen-only injectable.17 Return of fertility can be
delayed for up to 1 year after discontinuation of the progestogen-only injectable,17 which
may be unacceptable to those women who still wish to conceive, given the rapid decline in
background fertility in this age group.
C Women and their partners should be advised that very long-acting reversible contraception
can be as effective as sterilisation.
C Women should be advised that return of fertility can be delayed for up to 1 year after
discontinuation of progestogen-only injectable contraception.
4 © FSRH 2010
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extended regimen such as taking three pill packets continuously (tricycling), although such
use is outside the product licence.
C Women can be advised that in clinical practice CHC may reduce menopausal symptoms.
✓ Women experiencing menopausal symptoms while using CHC may wish to try an extended
regimen.
6.1.4 Ovarian and endometrial cancer
The risk of developing or dying from ovarian or endometrial cancer is reduced with use of
COC.37–50 The risk reduces with increasing duration of COC use; and whilst the protective
effect reduces over time, it may last for 15 years of more after use.38,42,44,47,50 A case control
study has suggested that this protective effect is more strongly associated with
premenopausal than postmenopausal disease.51 Data also suggest a reduction in the
incidence of ovarian cysts and benign ovarian tumours amongst women using COCs.52–55
B CHC use provides a protective effect against ovarian and endometrial cancer that continues
for 15 years or more after stopping CHC.
6.1.5 Benign breast disease
A decreased risk of benign breast disease and decreased risk of hospitalisation for
fibroadenoma and chronic cystic disease have been noted with use of COC,56–58 although
in all studies confounding and bias cannot be excluded.
B Women can be advised that there may be a reduction in the incidence of benign breast
disease with CHC use.
6.1.6 Colorectal cancer
Studies on the risk of colorectal cancer with COC use are reassuring, with epidemiological
data consistently indicating a decreased risk with use of COCs.59–65 The protective effect
appears to be associated with current or recent use and there is currently no evidence of a
duration-risk relation.
B Women can be advised that there may be a reduction in the risk of colorectal cancer with
CHC use.
6.1.7 Breast cancer
The annual risk of breast cancer increases with increasing age irrespective of hormone use.
Overall there is no clear evidence as to the risk of breast cancer with use of CHC. A
collaborative re-analysis of early case-control studies showed an increased risk of breast
cancer while using COCs,66 with a subsequent meta-analysis showing an increased risk of
premenopausal breast cancer.67 However, other well-conducted observational studies have
found no increased risk or a very small increased incidence of breast cancer or breast cancer
in situ.37,41,68–70 Any increased risk associated with use has been shown to decrease with time
since stopping, reducing to no significant risk 10 years after cessation.66 CHC methods
represent an unacceptable health risk for women with current breast cancer (UKMEC 4).10
A systematic review has concluded that, based on recent evidence, women who have a
family history of breast cancer do not increase their risk of breast cancer by using COC.71 A
family history of breast cancer is a condition for which the use of CHC methods is unrestricted
(UKMEC 1).10
The evidence is mixed on whether women who are carriers of BRCA1 or BRCA2 mutations
have an increased risk of breast cancer with COC use.72–78 Current guidance is that having a
genetic mutation associated with breast cancer is a condition for which the theoretical or
proven risks of using CHC generally outweigh the benefits. In these circumstances, provision
requires expert clinical judgement and/or referral to a specialist contraceptive provider, since
use of the method is not usually recommended unless other more appropriate methods are
not available or not acceptable (UKMEC 3).10
B Women can be advised that there may be a small additional risk of breast cancer with CHC
use, which reduces to no risk 10 years after stopping CHC.
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6 © FSRH 2010
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Table 3 UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) categories for the use of combined hormonal
contraception with cardiovascular and cerebrovascular disease10
Condition UKMEC
category
When prescribing CHC methods to women aged over 40 years, first choice of pill should be
the one containing the lowest dose of EE that provides adequate cycle control.
B Women who are aged 35 years or over and smoke should be advised that the risks of using
CHC usually outweigh the benefits.
B Clinicians should be aware that there may be a very small increased risk of ischaemic stroke
with CHC use.
C Women with cardiovascular disease, stroke or migraine with aura should be advised against
the use of CHC.
✓ Practitioners who are prescribing CHC to women aged over 40 years may wish to consider a
pill with <30 µg EE as a suitable first choice.
B Hypertension may increase the risk of stroke and MI in those using CHC.
C Blood pressure should be checked before and at least 6 months after initiating a woman
aged over 40 years on a CHC method and monitored at least annually thereafter.
7 Progestogen-only Contraception
There are currently four methods of progestogen-only contraception (POC) available in the
UK: the progestogen-only pill (POP), injectable, implant and the levonorgestrel-releasing
intrauterine system (LNG-IUS). The FSRH has produced detailed guidance on each of these
methods, which should be referred to for more detailed information.14,15,17,113
7.1 Health benefits and risks associated with POC
The benefits and risks associated with POC are less well studied than CHC and most of the
data relate to the use of the POP and injectable methods. Studies may be liable to a degree
of prescriber bias, as women who use these methods may be more likely to have underlying
disease which precludes CHC use.
7.1.1 Reproductive cancers
The evidence of an association between breast cancer and progestogen-only methods is
inconclusive. Of the studies examining the effects of hormonal contraception on breast
cancer, only small numbers of women have used progestogen-only methods and therefore
evidence is limited.15 Some studies have suggested a risk broadly similar to that of COC;66
however, other studies have suggested no increased risk or a very small increased risk.37,41,68
A recent case-control study has suggested there may be an increased risk of breast cancer
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associated with use of the LNG-IUS either alone [odds ratio (OR) 1.45, 95% confidence interval
(CI) 1.97–1.77] or in conjunction with estrogen (OR 2.15, 95% CI 1.72–2.68) in postmenopausal
women.114 However, this paper did not adjust for age at menopause. Overall, most evidence
is reassuring with regards to progestogen-only methods and risk of breast cancer.
A study80 that re-analysed data from 24 epidemiological studies has indicated that there is a
small increase in the risk of cervical cancer associated with long duration of progestogen-only
injectable contraceptives (>5 years) [relative risk (RR) 1.22, 95% CI 1.01–1.46)]. The risk is smaller
than that for CHC methods and the finding is based on far fewer women.
B Women can be informed that there is no conclusive evidence of a link between progestogen-
only methods and breast cancer.
7.1.2 Menopausal symptoms
There are some older studies that suggest depot medroxyprogesterone acetate (DMPA) may
help to alleviate vasomotor symptoms.115,116
7.1.3 Dysmenorrhoea
Dysmenorrhoea and ovulatory pain that are not associated with any identifiable pathological
condition may be alleviated by hormonal methods that inhibit ovulation such as the
desogestrel POP, the progestogen-only implant and injectable hormonal
contraceptives.117,118
Whilst there is generally a lack of data from randomised controlled trials on which to draw firm
conclusions about the role of progestogens in the treatment of pain associated with
endometriosis,119 there are some studies that suggest the LNG-IUS and DMPA may have
beneficial effects.120–125 Both DMPA and the LNG-IUS are acknowledged as possible
treatments in the Royal College of Obstetricians and Gynaecologists (RCOG) guideline on the
investigation and management of endometriosis.126
C Progestogen-only methods may help to alleviate dysmenorrhoea.
7.1.4 Bleeding patterns
Abnormal bleeding is common in women using POC and is often cited as a reason for
discontinuation.15,17,113 However, individual response varies and for some individuals
progestogen-only methods may be useful in the management of heavy menstrual bleeding
and irregular bleeding because of the associated amenorrhoea.
The LNG-IUS is licensed for use in the management of idiopathic menorrhagia14,127 and may
therefore be a very useful treatment option for heavy menstrual bleeding, which is particularly
common in women aged over 40 years. A Cochrane review has shown the LNG-IUS to be
more effective than cyclical norethisterone but results in a smaller mean reduction in
menstrual blood loss than endometrial ablation.128 Quality of life measures are generally
similar when comparing the LNG-IUS with endometrial ablation or hysterectomy, although
LNG-IUS users may experience more progestogenic side effects.128
Women considering POC should be advised regarding possible bleeding patterns, including
infrequent or no bleeding. Guidelines are available for practitioners on how to manage
women experiencing unscheduled bleeding whilst using hormonal contraception.129
Guidance on the investigation of women with heavy menstrual bleeding has been produced
by NICE29 but is outside the remit of this guidance. Women over the age of 45 years with
excessive bleeding should undergo an endometrial assessment.
✓ Women should be advised that altered bleeding patterns are common with use of POC.
B Women should be advised that the LNG-IUS can be used for the treatment of heavy menstrual
bleeding once pathology has been excluded.
7.1.5 Bone health
Most of the concern regarding BMD and progestogen-only methods relates to the long-term
use of the progestogen-only injectable, DMPA. It is recognised that use of DMPA does affect
BMD; however, there is a suggestion that BMD may recover upon cessation of use.12,130 Data
on fracture risk associated with DMPA use are limited.
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In terms of advising women aged over 40 years, there is some relatively reassuring evidence
from small studies to support use in women approaching the menopause.131–133 A cohort
study (n = 496) of DMPA users aged 40–49 years reported no significant differences in BMD
between users of DMPA, NET-EN, COC and non-user controls,132 whilst another study that
compared the BMD of women aged 43–58 years who had used DMPA or an intrauterine
device (IUD) until the menopause found that no significant differences were observed at 1
and 2–3 years following the menopause.133 Over the age of 45 years, use of DMPA is UKMEC
Category 2 (i.e. the benefits usually outweigh the theoretical or proven risks). There is no upper
age limit specified in UKMEC. The CEU supports the use of DMPA until the age of 50 years,
providing clinicians adhere to utilising the following advice issued by the Department of Health
Medicines and Healthcare products Regulatory Agency (MHRA):134
● A re-evaluation of the risks and benefits of treatment for all women should be carried out
every 2 years in those who wish to continue use.
● For women with significant lifestyle and/or medical risk factors for osteoporosis, other methods
of contraception should be considered.
There is currently no evidence of a clinically significant effect of other progestogen-only
methods on BMD.
B Women should be informed that the progestogen-only injectable is associated with a small
loss of BMD, which usually recovers after discontinuation.
✓ Women who wish to continue using DMPA should be reviewed every 2 years to assess the
benefits and risks. Users of DMPA should be supported in their choice of whether or not to
continue using DMPA up to a maximum recommended age of 50 years.
7.1.6 Cardiovascular and cerebrovascular disease
The limited data available from observational studies suggest that use of POC is not
associated with an increased risk of stroke135 or MI136 and that there is little or no increase in
Table 4 UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) categories for the use of progestogen-only methods
with cardiovascular and cerebrovascular disease10
VTEa
Personal history of VTE 2 2 2 2
Current VTE (on anticoagulants) 2 2 2 2
Family history of VTE
(i) First-degree relative aged <45 years 1 1 1 1
(ii) First-degree relative aged ≥45 years 1 1 1 1
Hypertension
(a) Adequately controlled hypertension 1 2 1 1
(b) Consistently elevated blood pressure
levels (measurements taken properly)
(i) Systolic >140–159 mmHg or 1 1 1 1
diastolic >90–94 mmHg
(ii) Systolic ≥160 mmHg or 1 2 1 1
diastolic ≥95 mmHg
(c) Vascular disease 2 3 2 2
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the risk of VTE.89 However, because of the adverse effect of progestogens on lipid metabolism,
there is a theoretical risk of vascular disease in women with additional risk factors. DMPA has
a greater effect on lipid metabolism than other progestogen-only methods, hence the more
restrictive categories in UKMEC.10 Table 4 outlines the UKMEC categories for use of POC with
cardiovascular and cerebrovascular disease.
B Women can be advised that although the data are limited, POC does not appear to increase
the risk of stroke or MI, and there is little or no increase in VTE risk.
C Caution is required when prescribing DMPA to women with cardiovascular risk factors due to
the effects of progestogens on lipids.
8 Non-hormonal contraception
8.1 Copper-bearing intrauterine device
Menstrual bleeding problems are common in women aged over 40 years and also common
in users of intrauterine methods. Spotting, heavier or longer periods and pain are common in
the first 3–6 months following Cu-IUD insertion.14 These bleeding patterns are not harmful and
usually settle with time; however, women should be advised to seek medical advice to
exclude gynaecological pathology and infection if the bleeding problems persist or occur as
a new event.
A sexual health history should identify women at risk of STIs. Appropriate screening for STIs
should be offered to those at risk or to those who request testing prior to IUD insertion.14 Further
information can be found in Faculty guidance on intrauterine methods.14
C Women should be informed that spotting, heavier or prolonged bleeding and pain are
common in the first 3–6 months of Cu-IUD use.
8.2 Sterilisation
Individuals considering sterilisation should be advised about all methods of contraception
including LARCs. Information should be given on the advantages and disadvantages of
sterilisation, including the lower failure rate and lower risk of major complications associated
with vasectomy compared to laparoscopic tubal occlusion.137 Hysteroscopic sterilisation is a
less invasive alternative to laparoscopic sterilisation but its availability in the UK is currently
limited. The RCOG provides guidance on sterilisation.137
8.3 Barrier contraception
There is no restriction on the use of barrier methods based on age alone and there are few
conditions that would restrict their use.10
Use of spermicide with diaphragms and caps is still recommended.138 However,
condoms should not be used with the spermicidal product, nonoxinol-9 (N-9), due to the risks
of HIV transmission associated with mucosal irritation caused by frequent use.139 Oil-based
lubricants can damage condoms and so lubricants used with condoms should be non-oil-
based.
C Men and women can be advised that when used consistently and correctly, male condoms
and female condoms are, respectively, up to 98% and 95% effective at preventing
pregnancy.
C Women can be advised that when used consistently and correctly with spermicide,
diaphragm and caps are, respectively, estimated to be between 92% and 96% effective at
preventing pregnancy.
B When using lubricant with latex condoms a non-oil-based preparation is recommended.
8.4 Natural family planning
The numbers of women over the age of 40 years who rely on fertility awareness methods are
unknown. When approaching the menopause, natural family planning may become more
difficult due to menstrual cycle irregularity and the increase of anovulatory cycles making it
difficult to interpret ovulatory mucus.
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8.5 Withdrawal
Though not promoted as a method of contraception, use of withdrawal (coitus interruptus) is
reported by approximately 6% of women aged 40–44 years of age and 4% of women aged
45–49 years.11 A recent review has suggested that data on withdrawal use may
underestimate the numbers of couples actually using this method and that more research is
needed.140 Withdrawal, if used correctly (i.e. withdrawal before ejaculation every time), may
work for some couples, particularly as a backup to other methods. However, couples
considering withdrawal should be made aware that it may be less effective than other
methods of contraception.
9 Emergency Contraception
There are no restrictions on the use of emergency contraception (EC) based on age alone.
EC should be mentioned when discussing contraceptive options as women aged over 40
years may not know how to access EC or how long after unprotected sexual intercourse (UPSI)
it can be used.
There are now three methods of EC available in the UK: progestogen-only emergency
contraception (POEC), the Cu-IUD and the progesterone-receptor modulator, ulipristal
acetate. All three methods can be used up to 120 hours (5 days) after UPSI; however, POEC is
only licensed for use up to 72 hours and its effectiveness decreases with time.141 The Cu-IUD is
thought to be the most effective emergency contraceptive, preventing around 99% of
expected pregnancies. It can be used up to 5 days after the earliest expected date of
ovulation regardless of the number of episodes of UPSI, and can also be used for ongoing
contraception.
Further information is provided in Faculty guidance on EC141 and the CEU’s new product
review of ulipristal acetate.142
✓ Women should be made aware of the different types of EC available including when they
can be used and how they can be accessed.
C Men and women should be advised that the use of condoms can reduce the risk of acquiring
and transmitting STIs.
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12 Stopping Contraception
Women may need advice on stopping contraception around the menopause (Table 5). In
general the CEU advises that contraception may be stopped at the age of 55 years; however,
this advice may need to be tailored to the individual woman. Women who are not using
hormonal contraception and who continue to have regular menstrual bleeding at the age of
55 years should continue with some form of contraception. Whilst UKMEC does not give an
upper age limit for the use of CHC or the progestogen-only injectable, the CEU does not
recommend use of these methods beyond the age of 50 years.17,152 Ideally women over 50
years should be advised to switch to an alternative method such as the POP, implant, LNG-IUS
or barrier method until the age of 55 years or until the menopause can be confirmed. Women
who have been diagnosed with premature ovarian failure may occasionally have
spontaneous return of ovarian activity and should be referred to a specialist for contraceptive
guidance.
12.1 Non-hormonal methods
Whilst there is very little evidence to inform how and when methods of contraception can be
stopped, traditional clinical practice has been that non-hormonal contraception can be
stopped 1 year after the last menstrual period in those aged over 50 years, and 2 years after
the last menstrual period in those under 50. The probability of menstruation (and possibly
ovulation) after a year of amenorrhoea for women aged over 45 years has been estimated
by WHO to be 2–10%.153
All Cu-IUDs are licensed for at least 5 years of use or longer.14 Although outside the
manufacturer’s recommended duration of use, Faculty guidance states that if inserted at or
after the age of 40 years, a Cu-IUD with ≥300 mm2 copper can be used until menopause has
been diagnosed.14
C After counselling (about declining fertility, risks associated with insertion, and contraceptive
efficacy), women who have a Cu-IUD containing ≥300 mm2 copper, inserted at or over the
age of 40 years, can retain the device until the menopause or until contraception is no longer
required.
✓ Women who continue to use their IUD until contraception is no longer required should be
advised to return to have the device removed.
12.2 Hormonal methods
As hormonal contraception can affect bleeding patterns, laboratory testing may have some
value in determining when contraception can be stopped.
Studies have shown that it is possible to measure FSH levels whilst using progestogen-only
methods of contraception.154,155 However testing may be best restricted to women over the
age of 50 years, as they are more likely to be menopausal.
✓ Women using exogenous hormones should be advised that amenorrhoea is not a reliable
indicator of ovarian failure.
✓ In women using contraceptive hormones, FSH levels may be used to help diagnose the
menopause, but should be restricted to women over the age of 50 years and to those using
progestogen-only methods.
✓ FSH is not a reliable indicator of ovarian failure in women using combined hormones, even if
measured during the hormone-free interval.
✓ Women over the age of 50 years who are amenorrhoeic and wish to stop POC can have their
FSH levels checked. If the level is ≥30 IU/L the FSH should be repeated after 6 weeks. If the
second FSH level is ≥30 IU/L contraception can be stopped after 1 year.
12 © FSRH 2010
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CHC Can be continued up to age 50 yearsa Stop CHC at age 50 years and switch to a non-hormonal
or progestogen-only method, then follow appropriate
advice
DMPA Can be continued up to age 50 yearsa Stop DMPA at age 50 years and choose from options
below:
✓ Women who have their LNG-IUS inserted for contraception at the age of 45 years or over can
use the device for 7 years (off licence) or if amenorrhoeic until the menopause, after which
the device should be removed.
© FSRH 2010 13
CEU GUIDANCE
active women who are not yet postmenopausal.157 In a small study of sequential HRT users
aged 42–52 years, HRT inhibited ovulation in only 40% of women with regular cycles and some
women who had been anovulatory or had irregular cycles prior to HRT did subsequently
ovulate on HRT.158 Measurement of FSH is largely unreliable whilst taking HRT. Most
perimenopausal women will use sequential HRT. Continuous combined regimens are not
appropriate in the perimenopause due to a high chance of irregular bleeding.
Randomised trials have shown that the LNG-IUS is effective in providing endometrial
protection from the stimulatory effects of estrogen replacement therapy.159–164 Data
presented to the regulatory authorities from these trials provided evidence of endometrial
protection with a duration of just under 5 years. Therefore the LNG-IUS is only licensed for use
for 4 years with HRT127 but may be used off licence for up to 5 years.
Theoretically replicating the dose of progestogen found in HRT preparations via POC may
provide sufficient endometrial protection against the effects of estrogen replacement.
However, there is currently no evidence to show that the POP, implant and injectable provide
such protection and no contraceptive other than the LNG-IUS is licensed to be used for such
a purpose.
C Women using HRT should be advised not to rely on this as contraception.
✓ Women can be advised that a POP can be used with HRT to provide effective contraception
but the HRT must include progestogen in addition to estrogen.
A Women using estrogen replacement therapy may use the LNG-IUS to provide endometrial
protection. When used as the progestogen component of HRT, the LNG-IUS should be
changed no later than 5 years after insertion (the licence states 4 years), irrespective of age
at insertion.
14 Follow Up
In addition to the method-specific recommendations, women should be advised that they
may return at any point if they experience any problems with their contraception, or change
in medical history that may influence contraceptive choice, or when they reach 50 years of
age.
Menstrual bleeding problems are common in women aged over 40 years, as is
gynaecological pathology. Women should be advised to seek medical advice at any time if
they develop new symptoms of pain, irregular or heavy bleeding, or if bleeding problems do
not settle within 3–6 months of IUD/IUS insertion.
After the menopause it is advised that intrauterine methods are removed, rather than left in
situ. Cases of actinomyces-like organisims (ALOs) and pyometra have very occasionally been
reported in postmenopausal women with IUDs. If the IUD/IUS cannot be removed easily in an
outpatient setting, individuals should be referred for specialist review.
14 © FSRH 2010
CEU GUIDANCE
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18 © FSRH 2010
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© FSRH 2010 19
CEU GUIDANCE
Gilly Andrews is an advisory board member for Bayer Schering Pharma. Marian Everett has received payment
for lecturing from Bayer Schering Pharma, Schering Plough, Novo Nordisk and Wyeth. No other competing
interests were noted by members of the multidisciplinary group.
CEU guidance is developed in collaboration with the Clinical Effectiveness Committee of the FSRH. The CEU
guidance development process employs standard methodology and makes use of systematic literature
review and a multidisciplinary group of professionals. The multidisciplinary group is identified by the CEU for
their expertise in the topic area and typically includes clinicians working in family planning, sexual and
reproductive health care, general practice, other allied specialties, and user representation. In addition, the
aim is to include a representative from the FSRH Clinical Effectiveness Committee, the FSRH Education
Committee and FSRH Council in the multidisciplinary group.
Evidence is identified using a systematic literature review and electronic searches are performed for:
MEDLINE (CD Ovid version) (1996–2010); EMBASE (1996–2010); PubMed (1996–2010); The Cochrane Library (to
2010) and the US National Guideline Clearing House. The searches are performed using relevant medical
subject headings (MeSH), terms and text words. The Cochrane Library is searched for systematic reviews,
meta-analyses and controlled trials relevant to the topic under consideration. Previously existing guidelines
from the FSRH (formerly the Faculty of Family Planning and Reproductive Health Care), the Royal College of
Obstetricians and Gynaecologists (RCOG), the World Health Organization (WHO) and the British Association
for Sexual Health and HIV (BASHH), and reference lists of identified publications, are also searched. Similar
search strategies have been used in the development of other national guidelines. Selected key publications
are appraised using standard methodological checklists similar to those used by the National Institute for
Health and Clinical Excellence (NICE). All papers are graded according to the Grades of Recommendations
Assessment, Development and Evaluation (GRADE) system. Recommendations are graded as in the table on
the inside front cover of this document using a scheme similar to that adopted by the RCOG and other
guideline development organisations. The clinical recommendations within this guidance are based on
evidence whenever possible. Summary evidence tables are available on request from the CEU. An outline of
the guideline development process is given in the table on the inside back cover of this guidance document.
20 © FSRH 2010
CEU GUIDANCE
The following discussion points have been developed by the FSRH Education Committee.
Discussion Points
2 Discuss how you would diagnose the menopause in a woman aged over 40 years who is using combined
hormonal contraception.
3 Discuss bone health in a woman aged over 40 years who is using depot medroxyprogesterone acetate.
The following questions and answers have been developed by the FSRH Education Committee.
Indicate your answer by ticking the appropriate box for each question True False
3 In women with a family history of breast cancer the use of COC increases the ■ ■
risk of developing breast cancer.
4 The risks of the progestogen-only pill (POP) use outweigh the benefits in women aged ■ ■
over 50 years.
9 A POP can be used with HRT to provide effective contraception in women aged over ■ ■
40 years.
10 The intrauterine device (IUD) should be removed 1 year after the last menstrual period ■ ■
in women aged over 50 years.
© FSRH 2010 21
NOTES
22 © FSRH 2010
NOTES
© FSRH 2010 23
NOTES
24 © FSRH 2010
NOTES
© FSRH 2010 25
NOTES
26 © FSRH 2010
STEPS INVOLVED IN THE DEVELOPMENT OF THIS
GUIDANCE DOCUMENT
Formulation of key clinical questions by the Clinical This process must be completed in a maximum
Effectiveness Unit (CEU). of 8 weeks.
Draft one guidance document is written providing The CEU has overall responsibility for writing the
recommendations and good practice points based guidance document. The multidisciplinary group
on the literature review. and other peer reviewers should highlight
inconsistencies, errors, omissions or lack of clarity.
Peer review by multidisciplinary group comprising At this stage the CEU convenes a one-day
stakeholders and including service user representation; meeting of the multidisciplinary group.
representation from the Faculty of Sexual and
Reproductive Healthcare (FSRH) Education Committee;
and where possible representation from the FSRH
Clinical Effectiveness Committee (CEC) and FSRH
Council.
Preparation of draft three guidance document based Minor comments can be accepted at this
on written comments from the peer review process. stage.
The final guidance document is published by the FSRH. Proofreading of guidance document by three
members of the CEU team independently and
comments collated by the Unit Director. A pdf
version of the guidance is available on the FSRH
website.
You will receive an automated acknowledgment on receipt of your comments. If you do not receive this
automated response please contact the CEU by telephone [+44 (0) 141 232 8459/8460] or e-mail
(ceu.members@ggc.scot.nhs.uk).
The CEU is unable to respond individually to all feedback. However, the CEU will review all comments
and provide an anonymised summary of comments and responses which are reviewed by the Clinical
Effectiveness Committee and any necessary amendments made.